Impacted Mandibular Third Molar
Conditions
Keywords
electrocautery, scalpel blade, impacted mandibular third molar
Brief summary
This randomized controlled trial aims to compare electrocautery and scalpel blade incisions during surgical extraction of impacted mandibular third molars. The study will evaluate postoperative pain, intraoperative blood loss, and wound healing in patients undergoing third molar surgery. A total of 78 participants will be randomly allocated in a 1:1 ratio to receive either a scalpel blade incision or an electrocautery incision under standardized surgical conditions.
Detailed description
Surgical extraction of impacted mandibular third molars is one of the most common procedures in oral and maxillofacial surgery. The type of incision used may influence postoperative outcomes, including pain, bleeding, and wound healing. Electrocautery offers simultaneous cutting and coagulation, potentially reducing intraoperative blood loss and improving surgical visibility, whereas scalpel incisions produce precise tissue cuts without thermal injury. This prospective, two-arm, parallel-group, randomized controlled trial will compare electrocautery and scalpel blade incisions in patients undergoing surgical extraction of impacted mandibular third molars. Seventy-eight participants will be randomly assigned to either Arm A (scalpel blade incision) or Arm B (electrocautery incision). All other surgical and perioperative variables, including local anesthesia, flap design, irrigation, suture material, and postoperative medications, will be standardized. The primary outcome is postoperative pain assessed using a Visual Analogue Scale at 24 hours, 48 hours, and 7 days. Secondary outcomes include intraoperative blood loss and wound healing assessed using the Landry Wound Healing Index at 1 and 4 weeks. The findings of this study will provide evidence regarding the most appropriate incision technique for impacted mandibular third-molar surgery.
Interventions
PROCEDUREscalpel blade incision
A sterile No. 15 stainless-steel scalpel blade will be used to make the mucoperiosteal flap incision during surgical extraction of the impacted mandibular third molar.
PROCEDUREelectrocautery incision
A fine electrocautery electrode in cutting mode at a standardized effective power setting will be used to make the mucoperiosteal flap incision during surgical extraction of the impacted mandibular third molar.
Sponsors
Riphah International University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
This is a single-blinded randomized controlled trial. The independent outcome assessor responsible for wound-healing and postoperative assessments will remain blinded to treatment allocation. The operating surgeon cannot be blinded because the incision techniques are visibly different.
Intervention model description
This is a prospective, two-arm, parallel-group, randomized controlled trial. Eligible patients requiring surgical extraction of an impacted mandibular third molar will be randomly allocated in a 1:1 ratio to either Arm A (scalpel blade incision) or Arm B (electrocautery incision) using a computer-generated randomization sequence. Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes prepared by a person not involved in surgery or outcome assessment. All other surgical and perioperative conditions will be standardized between the two groups, and postoperative pain, intraoperative blood loss, and wound-healing outcomes will be compared.
Eligibility
Sex/Gender
ALL
Age
15 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male and female patients. * Age 15 to 65 years. * Patients requiring surgical extraction of an impacted mandibular third molar. Patients classified as ASA I or ASA II. * Patients willing to provide written informed consent, or assent with parent/guardian permission where applicable, and attend scheduled follow-up visits
Exclusion criteria
* \* Patients with uncontrolled systemic disease or immuno-compromised status. * Patients with bleeding disorders or those taking anticoagulant/antiplatelet drugs that cannot be safely withheld according to physician advice. * Patients with pacemaker or implanted electrical cardiac device. * Pregnant or lactating patients. * Patients with acute infection, pericoronitis, facial space infection, or pus discharge at the surgical site at the time of surgery. * Patients requiring bilateral third-molar extraction in the same sitting. * Patients unwilling to participate or unable to return for follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative pain | 24 hours, 48 hours, and 7 days after surgery. | Postoperative pain at the surgical site will be assessed using a 0-10 Visual Analogue Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| intraoperative blood loss | During surgery (from first incision to final suture). | Total blood loss will be calculated as the increase in gauze weight plus the suction-canister volume after subtracting the recorded irrigation volume. Results will be reported in milliliters (mL). |
| wound healing | 1 week and 4 weeks after surgery. | Wound healing will be assessed using the Landry Wound Healing Index, scored from 1 (very poor) to 5 (excellent). |
Countries
Pakistan
Contacts
CONTACTMuhammad Usama, BDS/FCPS
CONTACTUzair Luqman, BDS/FCPS
PRINCIPAL_INVESTIGATORUzair Luqman, BDS/FCPS
department of ORAL AND MAXILLOFACIAL SURGERY ISLAMIC INTERNATIONAL DENTAL HOSPITAL
Outcome results
None listed